3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System

K241081 · Topcon Corporation · OBO · Jul 17, 2024 · Ophthalmic

Device Facts

• Record ID: K241081
• Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
• Applicant: Topcon Corporation
• Product Code: OBO · Ophthalmic
• Decision Date: Jul 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions. It is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures. It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population. All the above functionalities and indications are available in combination with IMAGEnet 6. Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

Device Story

Maestro2 is a non-contact ophthalmic device combining spectral-domain OCT (SD-OCT) with digital color fundus photography; includes anterior observation camera. Used with IMAGEnet6 software on an external PC. Modified to support OCT angiography (OCTA). Operates in clinics; used by eye care professionals. Inputs: OCT scans and fundus images. Outputs: Tomographic images, 3D reconstructions, and en-face vascular visualizations. Healthcare providers use outputs to visualize retinal/choroidal vascular structures and aid diagnosis/management of ocular diseases (e.g., AMD, diabetic retinopathy). Benefits: Non-invasive visualization of ocular pathology; quantitative comparison to normative databases.

Clinical Evidence

Prospective, multi-center, observational study (n=124 eyes; 38 normal, 86 pathology). Compared Maestro2 OCTA performance to CIRRUS HD-OCT and dye-based angiography. Endpoints: image quality response rate, visibility of anatomical vascular features, and PPA/NPA for pathological features (MA, RI/CD, CNV). Results: Image quality response rates 71.0-75.0%. PPA/NPA for MAs (96.6%/92.7% in 3x3mm scans), RI/CD (93.1%/85.4% in 3x3mm scans), and CNV (88.9%/82.7% in 3x3mm scans).

Technological Characteristics

Spectral-domain OCT (SD-OCT) using 840 nm SLD. Scan speed: 50,000 A-scans/sec. A-scan depth: 2.6 mm. Axial resolution: 6 μm; Transverse: 20 μm. Connectivity: PC-based linkage via Ethernet. Software: Maestro2 Main Ver.3.00, IMAGEnet6 Ver.4.01. Standards: IEC 60601-1, ISO 10940, ISO 10993, IEC 62304, DICOM.

Indications for Use

Indicated for adult population as a diagnostic aid for in vivo viewing, axial cross-sectional, and 3D imaging/measurement of posterior ocular structures (retina, retinal nerve fiber layer, macula, optic disc) and anterior ocular structures. Used for diagnosis, documentation, and management of ocular health and diseases. Combination with IMAGEnet6 aids visualization of vascular structures of the posterior segment (retina, optic disc, choroid).

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• CIRRUS HD-OCT with Software Version 10 (K181534)
• 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K233561)
• IMAGEnet6 Ophthalmic Data System (K232828)

Submission Summary (Full Text)

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July 17, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Topcon Corporation % Lena Sattler President Orasi Consulting 226 1st Street Bonita Springs, Florida 34134

#### Re: K241081

Trade/Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)); IMAGEnet6 Ophthalmic Data System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI, NFJ Dated: April 18, 2024 Received: April 19, 2024

### Dear Lena Sattler:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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## Indications for Use

510(k) Number (if known) K241081

#### Device Name

· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

- IMAGEnet6 Ophthalmic Data System
#### Indications for Use (Describe)

· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects.

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

- · IMAGEnet6 Ophthalmic Data System
The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/5/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized eyes or lenses, giving the logo a modern and technological feel.

#### 510(k) SUMMARY

#### I. General information

Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan

#### Contact person:

Lena Sattler President, Orasi Consulting Phone: [phone] Email: [e-mail]

#### Date Prepared:

July 16, 2024

### II. Subject device:

| Name of Device: | 1) 3D OPTICAL COHERENCE TOMOGRAPHY<br>3D OCT-1(type: Maestro2)<br>2) IMAGEnet6 Ophthalmic Data System |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| Device Class: | Class II |
| Classification Name: | 21 C.F.R. § 886.1570, Ophthalmoscope |
| Product Code: | OBO |
| Associated Product Code: | HKI, NFJ |

#### III. Predicate devices:

#### PRIMARY PREDICATE DEVICE:

| Company | Carl Zeiss Meditec, Inc. |
|----------------------|----------------------------------------|
| Device | CIRRUS HD-OCT with Software Version 10 |
| 510(k) No. | K181534 |
| Classification Name: | 21 CFR § 886.1570<br>Ophthalmoscope |
| Product Code: | OBO |

### SECONDARY PREDICATE DEVICES:

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Image /page/6/Picture/0 description: The image shows the logo for Topcon. The logo features a stylized blue symbol resembling two overlapping letter 'C' shapes. Below the symbol, the word "TOPCON" is written in a bold, sans-serif font, also in blue. The logo is simple and modern.

| (1) 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2): | |
|---------------------------------------------------------------|-------------------------------------------------------------|
| Company | Topcon Corporation |
| Device | 3D OPTICAL COHERENCE TOMOGRAPHY<br>3D OCT-1(type: Maestro2) |
| 510(k) No. | K233561 |
| Classification Name: | 21CFR § 886.1570 Ophthalmoscope |
| Product Code: | OBO HKI |

| | (2) IMAGEnet6 Ophthalmic Data System: | | |
|--|---------------------------------------|--|--|
| | | | |

| Company | Topcon Corporation |
|----------------------|------------------------------------------------------------------------|
| Device | IMAGEnet6 Ophthalmic Data System |
| 510(k) No. | K232828 |
| Classification Name: | 21 C.F.R. § 892.2050<br>Medical image management and processing system |
| Product Code: | NFJ |

#### IV. Brief Device Descriptions

### 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2) with system linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6).

The software version for this 510(k) are: Maestro2 Main software: Ver.3.00 PC Software for System Linkage: Ver.3.00

### IMAGEnet6 Ophthalmic Data System

IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices.

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Image /page/7/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized eyes or lenses, giving the logo a modern and technological feel.

When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

IMAGEnet6 also provides the GUI for remote operation. This function is an optional function which enables end-users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of Maestro2 via ethernet cable. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.

The software version for this 510(k) is: IMAGEnet6 Ophthalmic Data System Ver. 4.01

### V. Intended use

The Maestro2 has the same intended use as the primary predicate and IMAGEnet 6 has the same intended use as the secondary predicate K232828. The modified Maestro2 and IMAGEnet6 devices will have the following Indications for Use (IFU) statements, which are not substantially different from those of the primary and/or secondary predicates:

### Indications for Use

#### ● 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and nonmydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

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Image /page/8/Picture/1 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two curved shapes that resemble stylized wings or petals, with a horizontal line running through the center, creating a sense of connection or unity.

It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

#### IMAGEnet6 Ophthalmic Data System ●

The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

#### . Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

#### VI. Comparison of the technological characteristics between the subject and predicate devices

The subject and predicate devices do not share identical technological characteristics. However, these differences do not raise new or different questions of safety and effectiveness.

Comparison of the technological characteristics between the subject and predicate devices are summarized in Tables 1, 2 and 3 below.

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Image /page/9/Picture/0 description: The image shows the logo for TOPCON. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized eyes or lenses.

## TABLE 1: PREDICATE COMPARISON–MAESTRO2 AND IMAGENET6 VERSUS PRIMARY PREDICATE ON OCT ANGIOGRAPHY

| | (Under lines shows the differences.) | | | |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model<br>Number | Subject Device<br>3D OCT-1 Maestro2<br>Software version<br>Maestro2 Main software:<br>Ver.3.00<br>PC Software for System<br>Linkage: Ver.3.00 | Subject Device<br>IMAGEnet6<br>Software version Ver4.01 | Primary predicate device<br>CIRRUS HD-OCT | Substantial<br>Equivalence<br>Discussion |
| Trade Name | 3D OPTICAL<br>COHERENCE<br>TOMOGRAPHY 3D OCT-<br>1(type: Maestro2) | Ophthalmic Data System<br>IMAGEnet6 | CIRRUS HD-OCT | NA |
| 510(k)<br>submitter | TOPCON Corporation | TOPCON Corporation | Carl Zeiss Meditec, Inc. | NA |
| 510(k)<br>Number | K241081 | K241081 | K181534 | NA |
| Primary<br>Product code | OBO | OBO | OBO | Same |
| Regulation No. | 21 C.F.R. § 886.1570 | 21 C.F.R. § 886.1570*<br>*Due to bundling of<br>Maestro2 and IMAGEnet6<br>under the same 510(k)<br>submission | 21 C.F.R. § 886.1570 | Same |
| Product class | II | II | II | Same |
| Indications for<br>Use | The Topcon 3D Optical<br>Coherence Tomography 3D<br>OCT-1 (Type:Maestro2) is<br>a non-contact, high<br>resolution tomographic and<br>biomicroscopic imaging<br>device that incorporates a<br>digital camera for<br>photographing, displaying<br>and storing the data of the<br>retina and surrounding<br>parts of the eye to be<br>examined under Mydriatic<br>and non-Mydriatic<br>conditions.<br>It is indicated for in vivo<br>viewing, axial cross<br>sectional, and three-<br>dimensional imaging and<br>measurement of posterior<br>ocular structures, including<br>retina, retinal nerve fiber<br>layer, macula and optic<br>disc as well as imaging of<br>anterior ocular structures.<br>It also includes a Reference<br>Database for posterior<br>ocular measurements<br>which provide for the<br>quantitative comparison of<br>retinal nerve fiber layer,<br>optic nerve head, and the<br>macula in the human retina | The IMAGEnet6<br>Ophthalmic Data System is<br>a software program that is<br>intended for use in the<br>collection, storage and<br>management of digital<br>images, patient data,<br>diagnostic data and clinical<br>information from Topcon<br>devices.<br>It is intended for<br>processing and displaying<br>ophthalmic images and<br>optical coherence<br>tomography data.<br>The IMAGEnet6<br>Ophthalmic Data System<br>uses the same algorithms<br>and reference databases<br>from the original data<br>capture device as a<br>quantitative tool for the<br>comparison of posterior<br>ocular measurements to a<br>database of known normal<br>subjects. | CIRRUS™ HD-OCT is a<br>non-contact, high<br>resolution tomographic and<br>biomicroscopic imaging<br>device intended for in-vivo<br>viewing, axial cross-<br>sectional, and three-<br>dimensional imaging of<br>anterior and posterior<br>ocular structures. The<br>device is indicated for<br>visualizing and measuring<br>anterior and posterior<br>ocular structures, including<br>cornea, corneal epithelium,<br>retina, retinal nerve fiber<br>layer, ganglion cell plus<br>inner plexiform layer,<br>macula, and optic nerve<br>head.<br>The CIRRUS normative<br>databases are quantitative<br>tools indicated for the<br>comparison of retinal nerve<br>fiber layer thickness,<br>macular thickness,<br>ganglion cell plus inner<br>plexiform layer thickness,<br>and optic nerve head<br>measurements to a<br>database of normal<br>subjects. | Similar.<br>The combination<br>of Maestro2 and<br>IMAGEnet6 is<br>similar to the<br>CIRRUS HD-OCT.<br>Both are OCT<br>imaging systems<br>with a reference<br>database (RDB).<br>OCTA and fundus<br>camera features.<br>Clinical<br>performance<br>testing was<br>conducted on the<br>OCTA function of<br>Maestro2 (and<br>IMAGEnet6<br>combination) and<br>on the CIRRUS<br>HD-OCT. |
| (Under lines shows the differences.) | | | | |
| Model<br>Number | Subject Device<br>3D OCT-1 Maestro2<br>Software version<br>Maestro2 Main software:<br>Ver.3.00<br>PC Software for System<br>Linkage: Ver.3.00 | Subject Device<br>IMAGEnet6<br>Software version Ver4.01 | Primary predicate device<br>CIRRUS HD-OCT | Substantial<br>Equivalence<br>Discussion |
| Indications for<br>Use<br>of<br>the<br>combination of<br>the Maestro2<br>in conjunction<br>with<br>IMAGEnet6 | to a database of known<br>normal subjects.<br>It is indicated for use as a<br>diagnostic device to aid in<br>the diagnosis,<br>documentation and<br>management of ocular<br>health and diseases in the<br>adult population.<br>All the above<br>functionalities and<br>indications are available in<br>combination with<br>IMAGEnet 6. | Maestro2 in combination with IMAGEnet 6 is indicated as<br>an aid in the visualization of vascular structures of the<br>posterior segment of the eye including the retina, optic disc<br>and choroid. | Angiography is indicated<br>as an aid in the<br>visualization of vascular<br>structures of the retina and<br>choroid. (Model 5000<br>only.)<br>CIRRUS HD-OCT is<br>indicated as a diagnostic<br>device to aid in the<br>detection and management<br>of ocular diseases<br>including, but not limited<br>to, macular holes, cystoid<br>macular edema, diabetic<br>retinopathy, age-related<br>macular degeneration, and<br>glaucoma. | NA |
| Light Source | Spectral domain OCT<br>(SDOCT) using a super<br>luminescent diode (SLD)<br>with center wavelength 840<br>nm. | NA | Spectral domain OCT<br>(SDOCT) using a super<br>luminescent diode (SLD)<br>with center wavelength 840<br>nm. | Same |
| Scan Speed | 50,000 A-scans/sec | NA | 27,000 A-scans/sec<br>68,000 A-scans/sec for<br>OCT Angiography | Different.<br>There is a<br>difference in scan<br>speed.<br>Clinical<br>performance<br>testing was<br>conducted on the<br>OCTA function of<br>Maestro2 and<br>IMAGEnet6<br>combination and<br>on the CIRRUS<br>HD-OCT. |
| A-scan Depth | 2.6 mm (in tissue) | NA | 2.0 mm | Different.<br>Clinical<br>performance<br>testing was<br>conducted on the<br>OCTA function of<br>Maestro2 and<br>IMAGEnet6<br>combination and |
| (Under lines shows the differences.) | | | | |
| Model<br>Number | Subject Device<br>3D OCT-1 Maestro2<br>Software version<br>Maestro2 Main software:<br>Ver.3.00<br>PC Software for System<br>Linkage: Ver.3.00 | Subject Device<br>IMAGEnet6<br>Software version Ver4.01 | Primary predicate device<br>CIRRUS HD-OCT | Substantial<br>Equivalence<br>Discussion |
| | | | | on the CIRRUS<br>HD-OCT.<br>Different. |
| Resolution | Axial: 6 μm (in tissue)<br>Transverse: 20 μm<br>(in<br>tissue) | NA | Axial: 5 μm (in tissue)<br>Transverse: ≤15 μm | Clinical<br>performance<br>testing was<br>conducted on the<br>OCTA function of<br>Maestro2 and<br>IMAGEnet6<br>combination and<br>on the CIRRUS<br>HD-OCT. |
| Scan Patterns | For posterior<br>3D scan<br>- 12x9 mm (512x128)<br>- 6x6 mm (512x128)<br>Line scan<br>- 6 mm (1024)<br>- 9 mm (1024)<br>5LineCross scan<br>- 6 mm (1024) x 5 x 2<br>- 9 mm (1024) x 5 x 2<br>For anterior<br>Radial scan<br>- 6 mm x 12 (1024x12)<br>Line scan<br>- 3 mm (1024)<br>- 6 mm (1024) | NA | Macular Cube<br>- 6x6 mm (512x128)<br>- 6x6 mm (200x200)<br>Optic Disc Cube<br>- 6x6 mm (200x200)<br>5 Line Raster<br>HD (high-definition)<br>Raster<br>- HD 1 Line 100x<br>- HD 21 Line<br>- HD Radial<br>- HD Cross<br>- HD 5-Line Raster<br>Anterior Segment Cube<br>Scan<br>512x128<br>Anterior Segment 5-Line<br>Raster<br>HD Angle<br>Anterior Chamber<br>Wide-to-Angle<br>HD Cornea<br>Pachymetry | Similar |
| OCTA Scan<br>Patterns | Macular<br>- 3x3mm (256x256)<br>- 6x6mm (360x360)<br>Disc:<br>- 4.5x4.5mm (320x320)…